rf-fullcolor.png

 

April 9, 2024
by Jason Scott

Recon: Pfizer posts positive Phase 3 data for RSV vaccine in adults 18 and older; Novartis to cut 680 product development jobs

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer’s plot to win the RSV vaccine race (STAT) (Endpoints)
  • Pfizer RSV shot meets goals in trial of high-risk adults under age 60 (Reuters)
  • BrainStorm outlines plans for what may be final attempt to bring ALS drug to market (Endpoints)
  • Over a year after biosimilars started competing, AbbVie still holds 96% of Humira market, report says (Endpoints)
  • As FDA weighs another myeloma endpoint for accelerated approvals, experts say timely access is at stake (Fierce Pharma)
  • Moderna jumps as vaccine shows benefit in head and neck cancer in early study (Reuters)
In Focus: International
  • Novartis to cut 680 jobs in product development (Reuters)
  • Model Contract To Expedite UK Clinical Trial Negotiations Between Non-Commercial Sponsors & Companies (Pink Sheet)
  • EU Health Experts On How ‘Optimization’ Could Improve Benefit Of New Cancer Drugs (Pink Sheet)
  • Why Vital EU Guidance For Clinical Investigation Plans Is So Challenging To Read (MedTech Insight)
  • UK Body Proposes Contract To Expedite Clinical Trials (MedTech Insight)
Pharma & Biotech
  • Biotech startups post strongest financing numbers in two years (STAT)
  • Big biotech names roll out Seaport Therapeutics, as interest in neuropsychiatric drugs swells (STAT)
  • Acrivon draws in $130M; Vincerx Pharma's Ph1 metastatic tumor data (Endpoints)
  • Monsters, dinosaurs and superheroes: Why pharma is bringing characters back into the ad mix (Endpoints)
  • Two ex-bluebird leaders launch Nvelop with $100M to tackle the biggest problem in gene editing (Endpoints)
  • MarketingRx roundup: Study finds generic drugs gain ground, but docs still prefer brands; Pfizer lauded at AACR (Endpoints)
  • Updated: Steve Paul, Daphne Zohar reunite for another neuro startup after Karuna success (Endpoints)
  • CG Life adds Toolhouse to portfolio, snapping up digital agency to double in size (Fierce Pharma)
  • Advanced therapy CDMO Ascend nabs Florida manufacturing site and team from ocular gene therapy outfit Beacon (Fierce Pharma)
  • AACR: Detailed data spark glimmer of hope for Merck's Keytruda-Lynparza combo in lung cancer (Fierce Pharma)
Medtech
  • MassMutual is rolling out free genetic testing for members, a dicey area for life insurers (STAT)
  • Device made by company J&J is buying for $13 billion clears hurdle in independent study (STAT)
  • New liquid biopsy screening test for pancreatic cancer shows promise in early data (STAT)
  • Exclusive: Digital health venture firm Define Ventures hires industry vet Frank Williams (Endpoints)
  • UPDATED: Thermo Fisher plots 74 layoffs at California plasmid manufacturing site as demand swings (Fierce Pharma)
Government, Regulatory & Legal
  • Medicaid redetermination cost community health centers an average of $600K each (STAT)
  • HCA’s charity care filings are on hyperdrive (STAT)
  • US says SK Battery faces $77,200 in fines over employee health hazards (Reuters)
  • FDA slams Jubilant Generics, Canada's Contract Pharmaceuticals with Form 483s (Fierce Pharma)
  • UPDATED: In refiling $16.5B Catalent buyout pitch, Novo gives FTC more time for review (Fierce Pharma)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.